Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention

Last updated: March 26, 2025
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

1

Condition

Hiv

Lung Disease

Treatment

High-dose isoniazid

Standard dose of isoniazid

Low-dose isoniazid

Clinical Study ID

NCT05413551
65808
1R21AI172182-01
  • Ages > 18
  • All Genders

Study Summary

This trial is designed to determine whether modifying the dose of isoniazid for individuals according to their n-acetyltransferase 2 (NAT2) genotype could increase the probability of achieving equivalence of area-under-the-curve.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eligible for latent tuberculosis treatment by Brazil's national guidelines*

  • provides written informed consent to participate in the study

Exclusion

Exclusion Criteria:

  • Evidence of active tuberculosis or currently under evaluation for activetuberculosis

  • Receiving drugs that interact with Rifapentine (e.g. methadone, warfarin)

  • Known intolerance or hypersensitivity to isoniazid or rifapentine

  • Prior treatment for active or latent tuberculosis > 14 days

  • Close contact to isoniazid- or rifampicin-resistant tuberculosis (TB) case

  • Neutropenia (absolute neutrophil count <1000 cells/mm3)

  • Clinical diagnosis of active liver disease or alcohol dependence

  • alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times theupper limit of normal

Study Design

Total Participants: 72
Treatment Group(s): 3
Primary Treatment: High-dose isoniazid
Phase: 1
Study Start date:
March 23, 2023
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Federal University of Mato Grosso do Sul

    Campo Grande, Mato Grosso do Sul
    Brazil

    Active - Recruiting

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